Evaluating the Efficacy and Safety of the Synchronized Cardiac Support Treatment with the Icor Kit in Patients with Cardiogenic Shock - a Pivotal Study (Pulse SE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Xenios AG
- 入组人数
- 21
- 试验地点
- 4
- 主要终点
- Cardiocirculatory stabilization and end-organ perfusion
研究概览
简要总结
The study aims to investigate the safety and efficacy of the Synchronized Cardiac Support treatment wit the icor kit and the Xenios console with modified sensor box ECG and Software Version 3.2.4
详细描述
The current study hypothesizes that The SCS treatment with the icor kit provides sufficient support for cardiocirculatory function as indicated by a significant lactate reduction 24 hours on SCS treatment versus before treatment start.
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support.
Synchronized Cardiac Support describes an electrocardiogram (ECG)- triggered pulsatile VA-ECMO based on R-wave detection. During diastole the pump speed and thus the flow is increased and during systole the pump flow is been set on a relative minimum. This provides a mechanical circulatory support pulse with oxygenated blood during diastole.
The Synchronized Cardiac Support Treatment is used in a standard VA ECMO configuration by two femoral single vessel cannulas. Patients following cardiac resuscitation will undergo targeted temperature management 32- 36°C according to guideline.
The Duration of Treatment can be up to 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated by study patient/legal representative and investigator/authorised physician
- •Minimum age of 18 years
- •Patients in cardiogenic shock
- •Cardiogenic shock is defined as:
- •Systolic blood pressure < 90 mmHg for at least 30 min
- •Inotropes and/or vasopressors are needed to maintain systolic blood pressure > 90 mmHg
- •Clinical signs of heart insufficiency with pulmonary congestion
- •Signs of end organ hypoperfusion with at least one of the following criteria:
- •Cold, damp skin or extremities
- •Oliguria (≤ 30 mL/h)
- •Serum lactate > 3.0 mmol/L
排除标准
- •In case of female patients: pregnancy or lactation period
- •Participation in an interventional clinical study during the preceding 30 days
- •Previous participation in the same study
- •Age > 85 years
- •Cardiac arrest out of hospital with return of spontaneous circulation (ROSC) > 30 min
- •No flow time > 5 min
- •Mechanical causes for cardiogenic shock (ventricular septal defect of papillary muscle rupture)
- •Non-cardiogenic causes of shock (bradycardia, sepsis, hypovolemia, etc.)
- •Fever (Body temperature > 38.0 °C) or other evidence of sepsis
- •Onset of cardiogenic shock > 6 h before enrolment
- •Lactate > 16 mmol/L
- •Severe peripheral arterial occlusive disease precluding insertion of femoral arterial or venous catheters
- •Contra-indications for anticoagulation
- •Contra-indication for VA ECMO, e.g. unrecoverable heart and not a candidate for transplant or VAD
研究组 & 干预措施
venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization
Patients with cardiogenic shock, requiring a venoarterial extracorporeal membrane oxygenation (VA ECMO) for cardiocirculatory stabilization will be treated with Synchronized Cardiac Support (SCS).
干预措施: Synchronized Cardiac Support with the icor kit (Device)
结局指标
主要结局
Cardiocirculatory stabilization and end-organ perfusion
时间窗: up to 14 days
measured by the Change in Lactate Level
次要结局
- Cardiocirculatory stabilization and end-organ perfusion(up to 14 days)
- Extracorporeal Life Support (ECLS) Performance(up to 14 days)
- Maintain renal function(up to 14 days)
- Maintain gas exchange(up to 14 days)
- Thermoregulation(up to 14 days)